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Other News To Note

• Cellceutix Corp., of Beverly, Mass., signed an agreement with Girindus America Inc., of Cincinnati, for the manufacture of Kevetrin active pharmaceutical ingredient. Terms of the agreement were not disclosed. The material manufactured by Girindus will be used to do the last animal studies needed for the filing of an investigational new drug application, as well as for Phase I human trials.

• Crucell NV, of Leiden, the Netherlands, said a supranational organization awarded the first portion of new contracts worth $300 million for supplies of its Quinvaxem pediatric vaccine. The contracts cover the period ranging from 2010 to 2012, with the initial awarded amount expected to grow even further over those three years. Those contracts are in addition to the $500 million obtained over the 2007-2009 period. Quinvaxem is a fully liquid vaccine combining antigens for protection against five childhood diseases: diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type B.

• CSL Behring, of King of Prussia, Pa., said Helixate FS (recombinant hemophilic factor) was approved by the FDA for routine prophylaxis in children with hemophilia A who are 16 or younger and do not have pre-existing joint damage. The new indication was granted by the FDA after determining Helixate FS is safe and effective for routine prophylaxis, which can reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A.

• Gilead Sciences Inc., of Foster City, Calif., said it received a subpoena from the U.S. Department of Health and Human Services requesting documents about the development, marketing and sales of Ranexa (ranolazine) for chronic angina. The drug was developed and originally commercialized by CV Therapeutics Inc., of Palo Alto, Calif., a company acquired by Gilead in April. (See BioWorld Today, March 13, 2009.)

• Gloucester Pharmaceuticals Inc., of Cambridge, Mass., said the Oncologic Drugs Advisory Committee will meet Sept. 2 to review its new drug application for romidepsin in patients in cutaneous T-cell lymphoma. Romidepsin, a histone deacetylase inhibitor, has orphan drug designation for non-Hodgkin's T-cell lymphomas, including CTCL, and has a PDUFA date of Nov. 12.

• GlycoMimetics Inc., of Gaithersburg, Md., was awarded a grant from the National Heart, Lung and Blood Institute to evaluate its E-selectin small-molecule antagonists in animal models of vascular complications of diabetes. Earlier studies showed that E-selectin inhibitors improved blood flow by inhibiting leukocyte rolling and adhesion in diabetic mice.

• Protalix BioTherapeutics Inc., of Carmiel, Israel, said the FDA approved the company's treatment protocol for prGCD, its proprietary plant cell-expressed recombinant form of glucocerebrosidase for the treatment of Gaucher disease. The treatment protocol, an open-label trial, is designed to allow physicians and other care providers to treat patients of Gaucher disease with prGCD during the expected shortage of Genzyme's Cerezyme and thereafter. Patients enrolled in the protocol will continue to be treated with prGCD until its anticipated marketing approval from the FDA. The Phase III pivotal study is expected to conclude next month, and top-line results are expected in October. A new drug application is expected to be filed with the FDA by the end of the year.

• Targeted Genetics Corp., of Seattle, received a letter from the Nasdaq stock market indicating that the company has failed to regain compliance with Nasdaq listing rule 5550(a)(2), which requires companies listed on the Nasdaq Capital Market to maintain a minimum $1 bid price per share.

• TI Pharma, of Leiden, the Netherlands, said it has joined a new consortium to boost drug development for the treatment of two deadly diseases, African sleeping sickness and Leishmaniasis, which affect millions of people worldwide. A total budget of nearly €3.6 million (US$5 million) has been allocated over the next four years to develop drugs for those diseases. The consortium also includes IOTA Pharmaceuticals Ltd., of Cambridge, UK; Mercachem BV, of Nijmegen, the Netherlands; and Nycomed AS, of New York.

• Vasogen Inc., of Mississauga, Ontario, and privately held IntelliPharmaCeutics Corp., of Toronto, entered a definitive agreement under which Vasogen will merge with IPC and operate as a publicly traded entity to be called IntelliPharmaCeutics International Ltd. IPC is a specialty pharmaceutical company focused on developing and manufacturing new and generic controlled-release pharmaceutical products. Separately, Vasogen also entered an agreement with Cervus LP, of Calgary, Alberta, that will reorganize Vasogen prior to completion of the transaction with IPC and that will provide gross proceeds to Vasogen of about $7.5 million in nondilutive capital. Vasogen has received a letter from Nasdaq stating that the company has not regained compliance with listing requirements.

• Versartis Inc., of Redwood City, Calif., has hired SynCo Bio Partners, of Amsterdam, the Netherlands, to produce Versartis' lead drug candidate VRS-859, a novel GLP-1 analogue for monthly dosing to treat Type II diabetes. Under the agreement, SynCo will further develop the Versartis existing production process for VRS-859 and optimize the manufacturing process to increase yields for the forthcoming cGMP production. VRS-859 is a recombinant fusion protein containing exenatide and Xten, a novel hydrophilic amino acid sequence that prolongs the half-life of proteins and peptides.